Recon: Sanofi Wins EU Approval for Rare Blood Disorder; FDA Rejects Sunovion ADHD Drug

• FDA rejects Sunovion’s ADHD drug (PharmaTimes) (Press)
• First CRISPR clinical trial backed by U.S. companies launches (STAT) (BioCentury)
• Once charged with speeding up Eli Lilly’s slow-mo R&D group, Anne White is handed the reins at Lilly Oncology (Endpoints) (Fierce)
• Insurers Fret Over How To Pay For Gene Therapy As The Science Advances (Forbes)
• Pharma Cases to Watch In 2018's Home Stretch (Law360-$)
• Ex-Glaxo Scientist Cops to IP Theft for Chinese Pharma Co. (Law360-$)
• Genetic tests for certain cancers leave potential patients with tough decisions (CBS)

• Britain loses medicines contracts as EU body anticipates Brexit (The Guardian)
• Sanofi wins European approval for rare blood-clotting disorder treatment (Reuters) (BioCentury) (PharmaTimes) (Press)
• Fake, low quality drugs come at high cost (Reuters)
• Amryt On Targeting Rare Disease Space In The Middle East (Pink Sheet-$)jbjhk,hilyully87907p0p90 8         jl.juou9
• Janssen bags new EU approval for Darzalex (PharmaTimes) (Press)
• Chinese Regulators Reviewing Pair Of Beigene Therapies (BioCentury)
• Global orphan and rare dermatology market set to exceed $6 billion by 2024 (Pharmafile)
• Medtech firms get personal with digital twins (Reuters)
• Dechra Pharma says it is implementing ‘hard Brexit’ plan (Financial Times)
• Brexit Likely To Force ‘Refocusing’ Of Ambitious EU Network Strategy (Pink Sheet-$)
• First MENA MAb manufacturer gets EMA GMP certificate (PharmaLetter-$)
• Africa squeezed by burden of disease and lack of investment (Financial Times)
• Dutch doctors fight pharma company’s 500-fold drug price rise (Financial Times)
• Launch of Sustainable Development Goals themed issue of the Bulletin of the World Health Organization (WHO)

• Neglected Tropical Disease Designation Rejected For First Time By US FDA (Pink Sheet-$)
• Is Big Pharma really more evil than academia? (The Guardian)
• Ibalizumab in Multidrug-Resistant HIV — Accepting Uncertainty (NEJM) (Study)
• Pediatrics group encourages parents to steer clear of popular FluMist in favor of shots (STAT)
• What you need to know about the evolving regulatory landscape (BioPharmaDive)
• Merck To Build Case For Doravirine-Based HIV Products On Efficacy, Safety Differences (SCRIP-$)
• Big Data In Medicines Regulation Will Need ‘Considerable Change In Mindset’ (Pink Sheet-$)
• Can Amgen's new-and-improved Kyprolis kick-start myeloma sales? (Fierce)
• Insulin's High Cost Leads To Lethal Rationing (NPR)
• Opioid Prescribing Limits for Acute Pain — Striking the Right Balance (NEJM)
• A Pathway To Biopharma 3.0 (BioCentury)
• We spend too much effort treating diseases, not preventing them (CNBC)
• Weight-loss pills can help. So why don't more people use them? (NCB)
• Ark Licenses Roche's IPF Therapy (BioCentury)
• How Regulatory Innovation Lays The Foundation For New Business Models (BioCentury)
• How Harbour Biomed Plans Pipeline Growth After GIC-Led $85 Million Series B (BioCentury)
• OPDP Issues First Efficacy-Only Enforcement Letter in Over 3 Years (FDA Law Blog)
• Valsartan probe teaches FDA lesson about impurities in manufacturing (Fierce)
• Probiotics are drugs, so we should test them like drugs (Popular Science)
• Phone apps help heart patients remember meds (Reuters)
• FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles (Press)

• Abivax reports impressive results in clinical phase 2a trial of ABX464 as an oral treatment for ulcerative colitis patients (Press)
• New Roche study supports use of Lucentis in wet AMD (PharmaLetter-$)
• Kodiak Sciences Announces Completion of Enrollment in the Company's Phase 1 Safety and Tolerability Study in Patients with Retinal Disease (Press)
• Aquestive Therapeutics Announces Tentative FDA Approval for Sympazan™ (clobazam) Oral Film (Press)

• A Few Things SaMD Developers Should Know (MDDI)
• How a Design Tweak Triggered a CPAP-Related Product Recall (MDDI)
• Philips acquires pulse oximetry sensor maker Xhale Assurance (MassDevice)
• Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant (MassDevice)

• California hospital chain with ties to billionaire files for bankruptcy (Reuters)
• DOJ, MassBio Back Helsinn In High Court On-Sale Bar Fight (Law360-$)
• NIOSH launches new framework to tackle opioid crisis in the workplace (CDC)
• You’ll Never Guess Which Company Is Reinventing Health Benefits (NYTimes)

• FDA Advisory Committee Calendar

• Evox raises £35m for exosome therapeutics (PharmaTimes)
• New pharma code of practice could include warnings of medicines change for patients (Pharmaceutical Journal)
• Ukraine Widens Access To Essential Drugs For CV, Diabetes & Asthma (Pink Sheet-$)

• Change in the Japanese pharmaceutical market: Cradle of innovation or grave of corporate profits? (McKinsey)
• Manufacturing Questions For Fosun Subsidiary Resurface (BioCentury)
• Pay Day For Reata As Bardoxolone Progresses For Kidney Disease In Japan (SCRIP-$)

• Pharma Unit Owner Among 6 Held (Times of India)
• Pharma shares extend rally; Dr Reddy's, Sun Pharma hit 52-week high (Business Standard)
• Multinational pharma increasing operations and investment in India (PharmaLetter-$)
• Amid Pharma ‘Landmarks’ Cipla Develops Tenofovir Prodrug (SCRIP-$)
• DoP finalises modalities of interest subvention scheme on loans to help pharma units upgrade to WHO-GMP standards; 250 cos to get boost (PharmaBiz)
• J&J’s subsidiary hip replacement row: A detailed timeline of events that hit this global giant (Economic Times)
• MRPA opposes health ministry's draft rules on online sale of drugs (PharmaBiz)
• Patient advocacy groups sceptical about health ministry move to implement India’s first ‘charter of patients' rights’ (PharmaBiz)
• Drug Action Forum asks Maneka Gandhi to withdraw her complaint based on which Health Ministry restricted manufacture of oxytocin (PharmaBiz)

• Certificates of free sale and export certificates for medical devices (TGA)
• Industry involvement in panel for Australia’s Life Saving Drugs Program (PharmaLetter-$)

• Ebola Attacked Congo Again. But Now Congo Seems to Be Winning (NYTimes) (Reuters)
• Congo Republic says to launch vaccination drive after yellow fever outbreak (Reuters)

• Dr. Elizabeth Connell, Authority on Contraception, Is Dead at 92 (NYTimes)